Advanced pushrod and pushrod assembly features

ABSTRACT

A pushrod tip having a top and bottom jaw, wherein the top and bottom jaws are coupled together to form an opening, wherein the top jaw is capable of flexing towards the bottom jaw when the pushrod tip is passed through a lumen. A pushrod having a top and bottom jaw, each with a first and second side along a longitudinal axis of the pushrod; the top and bottom jaw are coupled together; and the top jaw comprises a notch on the first side of the pushrod. An insertion system having a handpiece with a channel(s); and a pushrod assembly having a pushrod and a plunger; the pushrod having a rail(s) that is configured to couple with the channel(s) of the handpiece. An insertion system having a handpiece with a detent(s) and a key(s); and a pushrod assembly having a pushrod, a plunger, and a nut lock that has a series of radial keyways and a groove. The groove of the nut lock is configured to mate with the detent(s), and the series of radial keyways are configured to mate with the key(s).

CROSS-REFERENCE TO RELATED PATENTS AND APPLICATIONS

This application claims priority to U.S. Provisional Application Nos.61/376,661, filed on Aug. 24, 2010; 61/467,584, filed on Mar. 25, 2011;and 61/500,564, filed on Jun. 23, 2011, each of which is herebyincorporated by reference in its entirety.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to devices, systems, and methods fordelivering an intraocular lens (IOLs) into an eye. More particularly,the invention relates to devices, systems, and methods in which advancedfeatures are incorporated into insertion devices to aid in ease ofinsertion of IOLs.

BACKGROUND OF THE INVENTION

It is estimated that 73% of Americans between the ages of 65 to 74 getcataracts. A cataract is a clouding of the eye's lens that impairs aperson's vision and, if left untreated, causes blindness. As a result,each year approximately 1.4 million people in the United States aloneundergo cataract surgery, whereby the clouded natural crystalline lensis removed and replaced with an intraocular lens (IOL) implant.

Surgeons implant IOLs not only as a replacement for the naturalcrystalline lens but also to alter the optical properties of (providevision correction to) an eye with an existing IOL or in which thenatural lens remains. IOLs often include an optically clear disk-likeoptic of about 6 mm in diameter, and preferably at least one flexiblefixation member or haptic which extends radially outward from the opticand becomes affixed in the eye to secure the lens in position.

The optics may be constructed of rigid biocompatible materials such aspolymethyl methacrylate (PMMA) or deformable materials such as siliconepolymeric materials, acrylic polymeric materials, hydrogel polymericmaterials, and the like. The deformable materials allow the IOL to berolled or folded for insertion through an injector or insertioncartridge and an incision into the eye. Once within the chamber of theeye, the IOL is expulsed from the injector and returns to its originalshape.

Injectors or inserters for delivering IDLs into the eye typically employa handpiece and a removable cartridge that receives the IOL and has ahollow insertion tube or cannula through which the folded IOL is passedusing a pushrod. Some inserters do without the cartridge. The insertermay be wholly or partly reusable, in which case the inserter orhandpiece is usually made of some type of metal alloy that can besterilized. Alternatively, disposable inserters made of less expensivematerials, such as plastics, remain in a sterile package until ready foruse. In some cases, the IOL is stored separately and transferred to aload chamber in the inserter or cartridge just prior to delivery. Oneparticularly useful arrangement wherein the cartridge folds over an IOLis disclosed in U.S. Pat. No. 4,681,102 to Bartell. A cartridge opens toreceive an IOL in a load chamber, and then folds closed and fits into aninjector. A syringe-like plunger in the injector pushes the IOL from theload chamber through a tapered tube into the eye. The IOL unfolds as itemerges from the tip of the tapered tube. Another such insertion systemis disclosed in Makker et al., U.S. Pat. No. 5,942,277. An example ofstoring an IOL in an inserter component is seen in U.S. Pat. No.7,156,854, filed May 28, 2003. In the '854 patent, a nozzle portion 12along with a removable stop 26 retains the IOL therein during storageand has internal ramps that assist in folding the IOL optic during animplant procedure. Also, U.S. Patent Publication No. 2008/0058830, filedJul. 17, 2007, discloses a number of configurations for pre-loading IOLsfor transfer to an insertion apparatus, and is expressly incorporatedherein. Another preloaded insertion system is illustrated in U.S. PatentPublication No. 2009/0318933, filed Jun. 23, 2008, which is herebyincorporated by reference in its entirety.

Despite the advances in the area of insertion devices, there remains aneed for devices and systems that increase the ease of use of inserters,including facilitating the insertion of IOLs, while reducing the risk ofdamage to both the insertion device and the IOL.

SUMMARY OF THE INVENTION

The present inventions disclose an insertion system, comprising ahandpiece having a longitudinal axis, a distal end, and a proximal end,a pushrod assembly having a distal end and a proximal end, wherein thepush rod assembly comprises a pushrod and a plunger; wherein the pushrodassembly couples with the handpiece along the longitudinal axis; whereinthe pushrod is coupled with the plunger and the pushrod is located onthe distal end of the push rod assembly and the plunger is located onthe proximal end of the pushrod assembly; a cartridge comprising adelivery tube at a distal end; wherein the cartridge is configured anddimensioned to couple with the distal end of the handpiece; a capcomprising a window and a port; wherein the cap is configured anddimensioned to couple with the distal end of the cartridge. According toan embodiment, the cartridge may further comprise one or more wings andthe cap may further comprise one or more clips, wherein the one or moreclips are configured and dimensioned to couple with the one or morewings. According to another embodiment, the cap may further comprise aninternal bevel inside the cap at a distal end, wherein the internalbevel is configured and dimensioned to couple with a bevel at the distalend of the delivery tube.

In an embodiment, a device comprises a cap have a longitudinal axis, adistal end, and a proximal end, wherein the cap comprises window and aport; wherein the window comprises a fill indicator. According to anembodiment, the port may be located at the distal end. In an embodiment,the cap may further comprise one or more clips, wherein the clips areconfigured and dimensioned to couple with one or more wings of acartridge. In another embodiment, the cap may further comprise aninternal bevel inside the cap near the distal end, wherein the internalbevel is configured and dimensioned to couple with a bevel at a distalend of a delivery tube.

According to an embodiment, an insertion system comprises a handpiecehaving a longitudinal axis, a distal end, and a proximal end, a pushrodassembly having a distal end and a proximal end, wherein the push rodassembly comprises a pushrod and a plunger; wherein the pushrod assemblycouples with the handpiece along the longitudinal axis; wherein thepushrod is coupled with the plunger and the pushrod is located on thedistal end of the push rod assembly and the plunger is located on theproximal end of the pushrod assembly; wherein the plunger comprises amarker configured and dimensioned to indicate axially translation of thepushrod assembly within the handpiece; and a cartridge comprising adelivery tube at a distal end; wherein the cartridge is configured anddimensioned to couple with the distal end of the handpiece.

According to another embodiment, an insertion system includes ahandpiece having a longitudinal axis, a distal end, and a proximal end;and a pushrod assembly having a distal end and a proximal end, whereinthe pushrod assembly comprises a pushrod and a plunger; wherein thepushrod assembly couples with the handpiece body along the longitudinalaxis; wherein the pushrod is coupled with the plunger and the pushrod islocated on the distal end of the pushrod assembly and the plunger islocated on the proximal end of the pushrod assembly; and wherein thepushrod or the handpiece comprises one or more guide rails, wherein theone or more guide rails are configured and dimensioned to couple withone or more channels of the pushrod or the handpiece. In an embodiment,the one or more guide rails have a substantially rectangular shape. Inanother embodiment, the one or more channels have a substantiallyrectangular shape. In an embodiment, there are two guide rails and twochannels and wherein one channel and one guide rail are larger than theother rail and channel. In another embodiment, the handpiece comprisesthe one or more channels and further comprises a holding station andwherein at least a portion of the one or more channels are locatedwithin the holding station; or the handpiece comprises the one or moreguide rails and the pushrod comprises the one or more channels, andwherein the handpiece further comprises a holding station wherein atleast a portion of the one or more guide rails are located within theholding station.

According to an embodiment, a pushrod includes a top jaw having a firstside and a second side along a longitudinal axis of the pushrod; and abottom jaw having a first side and a second side along the longitudinalaxis of the pushrod; wherein the top jaw and the bottom jaw are coupledtogether; and wherein the top jaw comprises a notch on the first sidealong the longitudinal axis of the pushrod that is configured anddimensioned to couple with an intraocular lens when the pushrod tip ispassed through a lumen. In an embodiment, the notch is L-shaped. Inanother embodiment, the notch extends beyond the top jaw into a body ofthe pushrod. In another embodiment, the bottom jaw comprises a notchalong a longitudinal axis of the pushrod that is configured anddimensioned to couple with an intraocular lens when the pushrod tip ispassed through a lumen. In another embodiment, the top jaw comprises asecond notch on the second side along the longitudinal axis of thepushrod. In another embodiment, the bottom jaw is longer than the topjaw. In an embodiment, the notch extends into a portion of the bottomjaw. In another embodiment, the top jaw comprises a second notch on thesecond side along the longitudinal axis of the pushrod. In anotherembodiment, the second notch extends into a portion of the bottom jaw.

According to an embodiment, an insertion system includes a handpiecehaving a longitudinal axis, a distal end, and a proximal end, a pushrodassembly having a distal end and a proximal end, wherein the pushrodassembly comprises a pushrod and a plunger; wherein the pushrod assemblycouples with the handpiece along the longitudinal axis; wherein thepushrod is coupled with the plunger and the pushrod is located on thedistal end of the push rod assembly and the plunger is located on theproximal end of the pushrod assembly; wherein the plunger is configuredand dimensioned to advance the pushrod toward the distal end of thehandpiece along the longitudinal axis by rotation of the plunger andtranslational movement of the plunger; wherein the plunger comprisesthreads and one or more safety detents, wherein the one or more safetydetents are located on a distal end of the plunger on one or more of thethreads; and wherein the one or more safety detents are configured anddimensioned to prevent advancement of pushrod with rotation of theplunger until such rotation is desired. In an embodiment, the one ormore safety detents are located within the first two or three threadsfrom the distal end of the plunger. In another embodiment, the threadscomprise one to six safety detents. The threads may also comprise foursafety detents.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is best understood with reference to the followingdetailed description of the invention and the drawings in which:

FIG. 1 is an assembled perspective view of an insertion system accordingto an embodiment of the invention;

FIG. 1A is an assembled perspective view of an insertion systemaccording to an embodiment of the invention;

FIG. 2 is a top view of an insertion system according to an embodimentof the invention;

FIG. 2A is a top view of an insertion system according to an embodimentof the invention;

FIG. 3 is a side view of an insertion system according to an embodimentof the invention;

FIG. 3A is a side view of an insertion system according to an embodimentof the invention;

FIG. 4 is a bottom view of an insertion system according to anembodiment of the invention;

FIG. 4A is a bottom view of an insertion system according to anembodiment of the invention;

FIG. 5 is an exploded view of the insertion system according to FIGS. 1and 1A;

FIG. 6 is a perspective view of a puller cap according to an embodimentof the invention;

FIG. 7 is a perspective view of a puller cap according to an embodimentof the invention;

FIG. 8 is cross-sectional view of a puller cap and insertion systemaccording to an embodiment of the invention;

FIG. 9 is cross-sectional view of a puller cap and insertion systemaccording to an embodiment of the invention;

FIG. 10 is an assembled perspective view of an insertion system with apuller cap according to an embodiment of the invention;

FIG. 11 is an assembled perspective view of an insertion system with apuller cap according to an embodiment of the invention;

FIG. 12 is an assembled perspective view of an insertion system with apuller cap according to an embodiment of the invention;

FIG. 13 is an assembled perspective view of an insertion system with apuller cap according to an embodiment of the invention;

FIGS. 14A-E are multiple views of a pin according to an embodiment ofthe invention;

FIG. 15 is a cross-sectional perspective view of a puller cap andinsertion system according to an embodiment of the invention;

FIG. 15A is a cross-sectional view of a pin, puller cap, and insertionsystem according to an embodiment of the invention;

FIG. 16 is a cross-sectional perspective view of a puller cap andinsertion system according to an embodiment of the invention;

FIG. 17 is a cross-sectional perspective view of a puller cap andinsertion system according to an embodiment of the invention;

FIGS. 18A-C are cross-sectional views of an alternate embodiment of thepuller cap;

FIG. 18D is a perspective view of the alternative embodiment of thepuller cap shown in FIGS. 18A-C;

FIG. 19A is a side view of a pushrod according to an embodiment;

FIG. 19B is a side view of a pushrod according to an embodiment;

FIG. 19C is a side view of a pushrod according to an embodiment;

FIG. 19D is a perspective view of pushrod according to an embodiment ofthe invention;

FIG. 19E is a side view of a pushrod according to an embodiment;

FIG. 20 is a cross-sectional perspective view of the pushrod in FIG.19D;

FIG. 21 is a cross-sectional view of a puller cap and insertion systemaccording to an embodiment of the invention;

FIG. 22A is a perspective view of the protective cap according to anembodiment;

FIG. 22B is a top view of the protective cap according to an embodiment;

FIG. 22C is a side view of the protective cap according to anembodiment;

FIG. 22D is a front view of the protective cap according to anembodiment;

FIG. 22E is a side view of the protective cap according to anembodiment;

FIG. 22F is a rear view of the protective cap according to anembodiment;

FIG. 22G is bottom view of the protective cap according to anembodiment;

FIG. 23A is a cross-sectional view of the protective cap shown in FIG.22F;

FIG. 23B is a cross-sectional view of the protective cap shown in FIG.22D;

FIG. 24A is a cross-sectional view of the protective cap shown in FIG.22B;

FIG. 25 is an assembled perspective view of an insertion system with aprotective cap according to an embodiment of the invention;

FIG. 26 is an assembled perspective view of an insertion system with aprotective cap according to an embodiment of the invention

FIGS. 27A-F are additional embodiments of a protective cap;

FIGS. 28A-F are additional embodiments of a protective cap;

FIGS. 29A-F are additional embodiments of a puller cap;

FIGS. 30A-F are additional embodiments of a puller cap;

FIG. 31A is a side view of an insertion system according to anembodiment;

FIG. 31B is a side view with a cutout portion of an insertion systemaccording to an embodiment;

FIG. 31C is a side view of an insertion system according to anembodiment;

FIG. 32 is a cross-sectional view of a rails and channels embodiment;

FIG. 33 is a perspective view of a nut lock according to an embodiment;

FIG. 33A is a cross-sectional view of a nut lock according to anembodiment;

FIG. 33B is a cross-sectional view of a nut lock according to anembodiment; and

FIG. 34 is a perspective view of a detent safety embodiment.

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to embodiments of the invention,examples of which are illustrated in the accompanying drawings. Whilethe invention will be described in conjunction with the embodiments, itwill be understood that they are not intended to limit the invention tothose embodiments. On the contrary, the invention is intended to coveralternatives, modifications, and equivalents, which may be includedwithin the spirit and scope of the invention as defined by the appendedclaims.

FIGS. 1-4 illustrate varying views of an exemplary IOL insertion system20 of the present invention comprising a twist/syringe-style devicehaving, generally, a handpiece 22, a plunger 24, and a delivery tube 26on a distal end/portion thereof. As illustrated in FIGS. 1-3, IOLinsertion system 20 may also include puller pin 100, which will bedescribed in greater detail below. As illustrated in FIG. 4, system 20also may comprise port 21 to enable application or insertion of a fluid,such as water, balance salt solution, and/or viscoelastic. FIGS. 1A-4Aillustrates an alternative IOL insertion system 20 of the presentinvention. The IOL insertion system 20 illustrated in FIGS. 1A-4A doesnot include puller pin 100 or port 21. It is also envisioned that IOLinsertion system 20 may include only one of the puller pin 100 or theport 21. The system 20 is also shown in an exploded view in FIG. 5.

IOL 31 is shown in FIG. 5 and may be positioned between two halves of aholding station 30. IOL 31 may comprise a central circular optic 32having a leading haptic 34 and a trailing haptic 36 generally spirallyextending therefrom. One exemplary IOL as illustrated is a one pieceacrylic Tecnis® brand of aspheric IOL available from Abbott MedicalOptics Inc. of Santa Ana, Calif. It is also envisioned that any IOL maybe used with the insertion system disclosed herein.

With reference to FIGS. 1-5 and FIGS. 1A-4A, the system 20 defines alongitudinal axis from an end cap 40 of a pushrod assembly 60 at aproximal end to the delivery tube 26 at a distal end. The pushrodassembly 60 includes a plunger 24, an end cap 40, a nut lock 102, and apushrod 61. Pushrod 61 may have a distal tip 62. In an embodiment, aportion of distal tip 62 may be flexible as described in greater detailbelow. In the illustrated embodiment, the distal tip 62 is forked toenable reliable capture of a proximal edge of the IOL optic 32 and/ortrailing haptic 36. The plunger 24 and/or pushrod 61 translates axiallythrough an elongate passage defined within the inserter handpiece 22 andis configured to urge the IOL from a holding station 30 through thedistal delivery tube 26. In a general sense, the plunger 24 representsany actuator capable of displacing the IOL from the holding station 30in a distal direction through a delivery tube or other such device. Theplunger 24 therefore may be generally termed an actuator so as toencompass other prime movers that can perform the same function, such asa rotary actuators, threaded actuators, levers, etc.

FIG. 5 is an exploded view of the components of the system 20 in theorientation in which they will be assembled. However, a preferred moldconfiguration results in a total of six (or possibly fewer) componentsfor the entire system, not counting the IOL. It is also envisioned thatthe mold configuration results in a total of seven or more componentsfor the entire system, not counting the IOL depending upon many factors,including but not limited to manufacturing requirements. The sixcomponents shown in FIG. 5 include the plunger 24, the pushrod 61, thecartridge 28, the nut lock 102, the upper body 56, and the lower body57. Lower body 57 may include the holding station 30 and base portion52. Cartridge 28 comprises delivery tube 26 and wings 27. It is possiblethat the handpiece upper body 56 could be formed along with theremainder of the handpiece, though the mold would be fairly complicatedand expensive. Likewise, the cartridge 28 could be incorporated into thehandpiece 22, but again for reasons of manufacturing economy they areseparate.

The one half of the holding station 30 comprises a base 50 that, in apreferred embodiment, forms a distal extension of a base portion 52 ofthe handpiece 22. The upper half of the holding station 30 comprises acover 54 that abuts the upper body 56 of the inserter handpiece 22. Inthe illustrated embodiment, as seen in FIG. 5, the cover 54 and upperbody 56 fit directly over the base 50 and base portion 52 to form theelongated handpiece 22. The overall shape of handpiece 22 may be of anyshape to accommodate proper gripping of the device. According to anembodiment, the holding station cover 54 may be connected by a pair ofliving hinges 80 a, 80 b to the base 50. The base 50 includes a pair ofbifurcated fingers 82 a, 82 b that meet a similar pair of bifurcatedfingers 84 a, 84 b extending from the cover 54 at the living hinges 80a, 80 b. The opposed pairs of aligned fingers 82, 84 are shaped so as toform slots therebetween when folded about the living hinges 80 and acentral cavity 86 (shown in FIG. 5) for receiving a delivery tube 26,the combination of which is best seen in the assembled view of FIGS. 1and 1A. In this regard, the delivery tube 26 desirably comprises arear-loading cartridge as shown, and as described in co-pending U.S.Patent Publication No. 2009-0270876, filed on Apr. 28, 2008, which ishereby incorporated by reference in its entirety. In an embodiment,hinges 80 a and 80 b may be a snap feature instead of living hinges. Insuch an embodiment, holding station cover 54 may be molded as a separatepart from base portion 52 and base 50.

The handpiece may further include a pair of proximal finger tabs 60 a,60 b, one on the base portion 52 and one on the upper body 56. When anoperator desires to depress the plunger 24, he or she places the thumbof one hand on the end cap 40, and index and middle fingers onrespective finger tabs 60 a, 60 b. Squeezing the hand closed depressesthe end cap 40 and moves the rest of pushrod assembly 60 along a lumenof the IOL insertion system 20 toward the distal end of the deliverytube 26.

Puller Cap

FIGS. 10-13 illustrate different views of system 20 with puller cap 70.Puller cap 70 fits over the holding station 30 and cartridge 28 in orderto protect these components, and in particular the delivery tube 26,while also facilitating the insertion of fluid as further describedbelow.

FIGS. 6 and 7 show two views of puller cap 70 of the present invention.In FIG. 6, puller cap 70 has a top 72, a bottom 73, a proximal end 75,and a distal end 85. Puller cap 70 includes lock 95A, 95B, grips 93,snap 90, and port 87. Puller cap 70 may be made of any material known inthe art, but preferably polypropylene, polycarbonate, polyethylene, orpolyethylene terephthalate; more preferably polypropylene andpolycarbonate; most preferably polypropylene. Puller cap 70 may also beof any color, preferably translucent or clear to enable a user tovisualize the features inside puller cap 70 and anything housed withinpuller cap 70. Puller cap 70 may be the shape as illustrated in theembodiment in FIG. 6, but the invention also envisions that puller cap70 may be of any shape or size to accommodate the needs of the insertionsystem the puller cap is used with or the needs of the user the pullercap is designed for. For example, the puller cap may be of an arrowshape as illustrated in the embodiment in FIG. 6, may be more of a roundshape, triangular shape, square shape, or shaped to meet the needs forshipping and/or handling. The puller cap may also include one or morehook features (not shown) to aid in the removal of the puller cap froman inserter. The hook feature may be located on any location on thepuller cap, including but not limited to the top, bottom, on or near thesnap, or near the distal or proximal ends. The hook feature may be ofany shape or size to accommodate for the shape or size of the puller capand may be of any shape or size to accommodate the fingers of a user.

The lock 95A and 95B may be of any design or configuration known in theart. According to an embodiment of the present invention, a portion 96of locks 95A, 95B are configured and dimensioned to cam outwardly whenexternal pressure is placed on the snaps in a perpendicular plane withrespect to the longitudinal plane of system 20 from proximal end 75 todistal end 85. (See FIG. 7). Locks 95A, 95B may comprise a texturedesign or feature to ease gripping and/or actuation of the snaps andremoval of puller cap 70 from an insertion system, such as insertionsystem 20 as illustrated in FIGS. 1-5 and 1A-4A. In an embodiment,puller cap 70 may have one or more grips having a texture design orfeature and the lock 95A and 95B are separated from the one or moregrips, such that squeezing of the grips does not deactivate locks 95Aand 95B.

As shown in FIG. 6, the snap 90 is designed and configured to couplewith pin 100 (see FIGS. 14 and 15). Snap 90 may be of any shape or sizeas long as it is configured and dimensioned to mate with pin 100.According to the embodiment in FIG. 6, snap 90 comprises a canopy 92 anda keyway 94. In another embodiment, snap 90 does not have a canopy andonly has keyway 94.

Puller cap 70 may include one or more ports 87 to aid in the insertionof a fluid, including but not limited to balanced salt solution, water,and/or viscoelastic. The one or more ports 87 mate with ports located onthe insertion system 20 to assist with filling a portion of the systemwith fluid to provide lubrication to the internal features of theinsertion system to aid in delivery of the IOL. With respect to port 87as illustrated in FIG. 6, port 87 acts a funnel mechanism into thedistal end of delivery tube 26. FIG. 7 illustrates a bottom view ofpuller cap 70 comprising port 88 and a window 89. The puller cap mayalso comprise one or more windows to provide the users with a visualindicator of the amount of fluid inserted into a portion of theinsertion system, as well as provide viewing of the distal end of acannula tip, which is typically used to inject a fluid. In anembodiment, the one or more windows may be located on the top, bottom orsides of the puller cap, preferably on the top or the bottom. The one ormore windows may also comprise a measuring devise such as a ruler toallow a user to measure or see the amount of fluid inserted into theinserter. The window 89 may also have a fill indicator 99 such that auser fills a portion of the insertion system until the fluid reachesfill indicator 99 indicating a proper and/or maximum fill has beenreached. The one or more windows may also comprise a material such thatwhen a fluid is inserted into the insertion system and viewed throughthe window light that is emitted through the window to the fluid ispolarized providing a visual indicator of the fluid within the inserter.

As is well known in the art, the small nature of the ports of insertionsystems known in the art can make it very difficult for doctors, nurses,and/or staff to locate openings for inserting fluids. The puller cap ofthe present invention solves this problem by providing a larger portwith a funnel feature that leads into the smaller ports of the insertionsystem. This enables a user to more easily direct a cannula tip 101 intoa delivery tube 26 or ports 87, 88 as illustrated in FIGS. 8 and 9.

Pin and Haptic Sweep Slot

FIGS. 14A-E shows pin 100 which includes top 105, stem 107, key 109, andlock 113. Top 105 comprises key 109 that may be of any shape orconfiguration so as to mate with snap 90. Lock 113 may be of any shapeor size and is configured to mate with grove 115 of haptic sweep slot117 of cover 54 (see FIG. 16). Lock 113 may also be located anywherealong stem 107 and the present invention also envisions more than onelock feature. Haptic sweep slot 117 may also be of any shape or size aslong as it is configured to mate with pin 100. According to anembodiment, haptic sweep slot 117 runs along the same longitudinal axisof system 20. In an embodiment, the length of the haptic sweep slot islonger in length than the width the slot. In an embodiment, the lengthof the haptic sweep slot is between about 0.150 inches (in.) (3.81millimeters (mm)) to about 0.170 in. (4.318 mm), preferably about 0.153in. (3.8862 mm), more preferably about 0.165 in. (4.191 mm). In anembodiment, the width of the haptic sweep slot is about 0.028 in.(0.7112 mm) to about 0.040 in. (1.016 mm), preferably about 0.030 in.(0.762 mm), more preferably about 0.035 in. (0.889 mm) Pin 100 isconfigured and dimensioned to be inserted into haptic sweep slot 117such that lock 113 and groove 115 are coupled together securing the twoparts together, but still enabling the pin 100 to move within hapticsweep slot 117. Groove 115 may also be of any shape or size as long asit is configured to mate with lock 113. In an embodiment, there may bemore than one groove in the haptic sweep slot. Groove 115 enables pin100 to maintain a substantially perpendicular orientation with respectto the longitudinal axis of system 20. According to an embodiment, thesubstantially perpendicular orientation assists with sweeping or foldingof trailing haptic 36 as further described below.

Pin 100 may comprise leg feature 125 (see FIG. 14A-14E); such thatpushrod 61 is capable of passing step 107 once pin 100 has been advancedforward to sweep trailing haptic 36. The leg feature 125 results in stem107 having a cut out or offset portion as shown in FIGS. 14A, B, C andE. To ensure that this leg feature 125 is in the correct orientationduring manufacture, lock 109 may comprise a one-way directional snapfeature or poke-oke as illustrated in an embodiment in FIGS. 14C and D.

In an embodiment, pin 100 is configured and dimensioned to penetrate orextend through cover 54 and base 50 or another portion of system 20 orsimilar device to sweep or fold a trailing or leading haptic or similarfeature of an IOL.

Puller Cap and Pin Function

As shown in FIGS. 10 and 15, as puller cap 70 is placed on system 20 tocover cartridge 28 and delivery tube 26, snap 90 mates or couples withpin 100 via key 109 and keyway 94. See FIG. 15A for a cross-sectionalview showing pin 100 coupled with snap 92 in keyway 94 and lock 113coupled with groove 115. In addition to the functions described above,puller cap 70 with pin 100 function to fold or sweep the trailing haptic36 in the distal direction prior to folding or moving the IOL in thedistal direction to insert the IOL into the eye. Folding or sweepingtrailing haptic 36 in the distal direction controls the location of thehaptic and prevents damage to the haptic during delivery of the IOL. Pin100 may also sweep the trailing haptic 36 over a portion of optic 32such that during movement of the IOL down the lumen of tube 26 at leasta portion of the trailing haptic 36 is captured in the fold or folds ofthe optic 32. Prior to the present invention a user would have tomanually use the distal end of a cannula to fold or sweep the trailinghaptic, which was difficult to do due to the small nature of the slot.Moreover, it was difficult to visualize whether the haptic was in factin place once the cannula moved the haptic. The present inventionovercomes these problems. Once puller cap 70 is coupled with pin 100 auser may use the easy to access one or more ports 87, 88 toinsert/inject fluid into system 20. Next, to sweep trailing haptic 36 auser may grasp and squeeze locks 95A, 95B to release the internal lockfeatures, e.g. portion 96 of lock 95A, B from wings 27. As puller cap 70is advanced distally from system 20 along the longitudinal axis ofsystem 20 pin 100 slides along haptic sweep slot 117 and lock 113 slidesin groove 115 as shown in FIG. 16. When pin 100 reaches the end ofhaptic sweep slot 117, pin 100 will release from snap 90, releasingpuller cap 70 from system 20 as shown in FIG. 17. At this point,trailing haptic 36 has been swept or folded into the proper positionwithout the use of another tool and the TOL is now ready for insertioninto the eye.

In an alternate embodiment, pin 100 may release from cover 54 withpuller cap 70. It is also envisioned that pin 100 may be connected toone or more arms and one or more hinges to aid in its connection topuller cap 70 and its release from system 20. FIG. 18A shows such analternate embodiment of the present invention. In FIGS. 18A-D, pin 100is connected to arm 123 which is connected to arm 124 via hinge 122.Arms 123 and 124 may further be coupled with puller cap 70 with hinge126 and 127 (as shown in FIGS. 18C and 18D) or by any other mechanismknown in the art. As puller cap 70 is moved distally along thelongitudinal axis of system 20 to sweep trailing haptic 36 pin 100 isadvanced along haptic sweep slot 117. When pin 100 reaches the end ofhaptic sweep slot 117, further advancement of puller cap 70 causes arm124 to lift up thereby lifting arm 123 and lifting pin 100 from hapticsweep slot 117 and releasing puller cap 70 from system 20. In anembodiment, haptic sweep slot 117 may comprise a ramp at one or bothends of the slot. In particular, a haptic sweep slot 117 may comprise aramp at the distal end 121 of the slot to aid in the release of pin 100and/or puller cap 70 after trailing haptic 36 has been swept or folded.According to another embodiment, only a single arm or a single hinge maybe used with pin 100. In another embodiment, one or more arms or one ormore hinges may used with pin 100.

In an embodiment, pin 100 maintains trailing haptic 36 in the properorientation for delivery and even if a user decides to place puller cap70 back onto system 20, the internal features of system 20 stillmaintain trailing haptic 36 in the proper orientation. This allows auser to determine when she would like to use and/or the order in whichshe will use the haptic sweep feature, the port features, and the tipprotection feature, which will be described further below.

Pushrod

FIG. 19A illustrates a pushrod capable of being used with the system 20.Pushrod 61 comprises a top jaw 63 and a bottom jaw 64 that form mouth67. Top jaw 63 may also comprise a lip 65 that protrudes from an upperportion 66 of top jaw 63. In an embodiment, lip 65 is configured anddimensioned to help catch trailing haptic 36 and keep trailing haptic 36in a swept/folded configuration. FIG. 19D illustrates an exemplarypushrod of the present invention modifying the features of FIG. 19A. InFIG. 19D a portion of the distal end of pushrod 61 is removed resultingin cutout portion or notch 68 to allow room for the IOL as it is foldedand/or compressed during insertion of the IOL into an eye. The cutoutportion 68 of pushrod 61 provides for less force on the walls ofdelivery tube 26 and less force on the IOL as it delivered preventingdamage to the IOL and delivery tube 26. In an embodiment, cutout portion68 comprises approximately half the diameter of the top jaw 63 for aportion of the distal end including the lip 65, while bottom jaw 63remains intact. Cutout portion 68 may extend proximally beyond top jaw63 into the body of pushrod 61. In an embodiment, a notch or cutoutportion may also extend or be placed into bottom jaw 64. It is alsoenvisioned that an additional notch or cutout similar to notch 68 can bemade on the opposite side of top jaw 63. Bottom jaw 64 may also have oneor more notches. In an embodiment, a cross-section view of cutoutportion 68 shows an L-shaped seat (see FIG. 20).

In an embodiment, lip 65 is configured to ride along at least a portionof an internal channel or groove located within handpiece 22. Lip 65provides more stability for the pushrod 61 as it is advanced within alumen of the handpiece 22 towards the distal end of the handpiece. Byhaving the lip 65 engage at least a portion of the internal channel, thedistal end of the pushrod is less likely to move from its desiredlocation within the lumen as the pushrod is advanced towards the distalend of the handpiece.

According to an embodiment, the distal end of pushrod 61 may have a topjaw 63 and a bottom jaw 64 that form mouth 67 as illustrated in FIG.19E-19H. As shown in FIG. 19E, top jaw 63 is shorter in length thanbottom jaw 64 and includes cutout portion 68. For such an embodimentsweeping of the trailing haptic by pin 100 or another means isunnecessary because the design of the distal end of pushrod 61 causesthe trailing haptic of an IOL to be swept or folded over the optic asthe pushrod assembly 60 travels down the lumen of the insertion systemtowards the distal end of the delivery tube. In an embodiment, the topjaw is designed to engage the trailing haptic of an IOL before thebottom jaw engages the lens body or edge of the optic. In an embodiment,the height of the top jaw is such that it configured to couple with atleast a portion of an internal channel of the handpiece, preferably thetop jaw is configured to couple with at least a portion of an internalchannel located in the staging area, more preferably the top jaw isconfigured to couple with an internal channel extending through thestaging area. In another embodiment, the blunt tip may a height that islarger than the height of a haptic, e.g. a trailing haptic.

In an embodiment, the distal end of pushrod 61 may comprise anothercutout portion 69 on the opposite side of the first cutout portion. Thesecond cutout portion 69 may also provides for less force on the wallsof delivery tube 26 and less force on the IOL as it delivered preventingdamage to the IOL and delivery tube 26. For example, as the IOL isadvanced down the delivery tube, the IOL is compressed. The secondcutout portion 69 provides space for an edge of the IOL to wrap aroundthe top jaw 63 and tuck into the second cutout portion 69. The secondcutout portion may be shorter or longer in length than the first cutoutportion 68, preferably shorter than the first cutout portion 68. Thewidth of the second cutout portion may be larger or smaller than thewidth of the first cutout portion, preferably small that the width ofthe first cutout portion. The second cutout portion 69 may create asubstantially L-shaped seat. In an embodiment, a notch or cutout portionmay also extend or be placed into bottom jaw 64. It is also envisionedthat an additional notch or cutout similar to cutout portion 68 and 69can be made on one or both sides of bottom jaw 64.

Similar to the lip 65 discussed above, in an embodiment, the top jaw 63illustrated in FIG. 19E-19H is configured to ride along at least aportion of an internal channel or groove located within handpiece 22.Coupling of the top jaw 63 with at least a portion of an internalchannel provides more stability for the pushrod 61 as it is advancedwithin a lumen of the handpiece 22 towards the distal end of thehandpiece. By having the at least a portion of top jaw 63 engage atleast a portion of the internal channel, the distal end of the pushrodis less likely to move from its desired location within the lumen as thepushrod is advanced towards the distal end of the handpiece. The forcesgenerated by moving the IOL down the lumen of the staging area and/orlumen of the cartridge can have a tendency to push or offset the distalend of the pushrod. Coupling the top jaw 63 with at least a portion ofthe internal channel or groove helps to counter this movement andmaintain the distal end of the pushrod in proper alignment, e.g.maintaining the distal end of the pushrod substantially on center of thelumen of the handpiece. In an embodiment, the internal channel or grooveruns the length of the staging area.

In an embodiment, the top jaw 63 may have a blunt tip 71 and a roundedtop portion 74. The blunt tip 71 sweeps or folds the trailing haptic ofan IOL over the optic as the pushrod assembly 60 travels down the lumenof the insertion system towards the distal end of the delivery tube. Thetop jaw 63 and the bottom jaw 64 may have a rounded leading edge 76.Rounding the leading edge prevents damage to an IOL as it is moved downthe lumen of an insertion system.

In an embodiment, pushrod 61 has a tapered portion around thecircumference of the pushrod starting at or near the back of mouth 67and extends a long a length of the pushrod. In an embodiment, thetapered portion extends approximately ⅔ the total length of pushrod 61.As shown in FIG. 19F, beginning at or proximally near the back of themouth 67, the diameter of the tapered portion gradually gets smalleruntil approximately the midline of the tapered portion and then beginsto gradually get larger until it reaches the largest diameter of thepushrod 68. The smallest diameter of the tapered portion may occur atthe halfway point of the entire length of the tapered portion. In anembodiment, the smallest diameter occurs beyond the halfway point of theentire length of the tapered portion in the proximal direction. Thelength of the tapered portion may be between about 0.280 in. (7.122 mm)and about 0.325 in. (8.255 mm). The diameter of the pushrod at itslargest diameter may be between about 0.080 in. (2.032 mm) and about0.060 in. (1.524 mm), preferably 0.070 in. (1.778 mm); and the smallestdiameter of the tapered portion may be between about 0.045 in. (1.143mm) and about 0.060 in. (1.524 mm). The tapered portion provides forspace and/or allows for a trailing haptic to wrap around the pushrodshould the haptic not fold over the optic, which prevents the IOL frombeing damaged or broken off from the rest of the IOL.

In an embodiment, cutout portion or notch 68 may extend into a portionof the tapered portion. Cutout portion 68 is designed as a safetyfeature to (1) provide space for the folding IOL as it is advanced downa tapered lumen; (1) allow for a trailing haptic to wrap around thepushrod and/or guide the trailing haptic around the tapered portionshould the haptic not fold over the optic; (3) allow for extension of atrailing haptic that does not get folded; and/or (4) allow space forshoulder or bend that is created near the optic-haptic junction when thetrailing haptic is folded over the optic, which prevents the IOL frombeing damaged or broken off from the rest of the IOL. In an embodiment,the cutout portion 68 may have a length between about 0.150 in. (3.81mm) and about 0.300 in. (7.62 mm), a height between about 0.030 in.(0.762 mm) and about 0.050 in. (1.27 mm), and a width between about0.040 in. (1.016 mm) and about 0.065 in. (1.651 mm). The length of thecutout portion 68 may also be longer or shorter than the full extensionof an TOL haptic. Cutout portion 68 may begin at or near the tip ofpushrod 61 or at or near the back of the mouth 67 and continue a lengthof the pushrod 61. The cutout portion 68 may continue a length of thepushrod 61 with its width gradually tapering out or becoming smalleruntil it meets the side of the pushrod (see FIG. 19G).

The features of pushrod 61 as shown in FIGS. 19A-19D may have variousdimensions. The length of the cutout portions 68 may be between about0.145 in. (3.683 mm) to about 0.165 in. (4.191 mm), preferably betweenabout 0.149 in. (3.7846 mm) to about 0.160 in. (4.064 mm), morepreferably about 0.149 in. (3.7846 mm) or about 0.160 in. (4.068 mm).The width of upper portion 66 of top jaw 63 may range from about 0.015in. (0.381 mm) to about 0.030 in. (0.762 mm), preferably about 0.023 in.(0.5842 mm). The diameter or width A of cutout portion 68 as shown inFIG. 20 may be between about 0.015 in. (0.381 mm) to about 0.025 in.(0.635 mm), preferably about 0.019 in. (0.4826 mm). According to anembodiment, the diameter A of cutout portion 68 may be inverselyproportional to the width of the upper portion 66 of top jaw 63. Theheight of lip 65 that protrudes up may be between about 0.003 in.(0.0762 mm) to about 0.012 in. (0.3048 mm), preferably about 0.006 in.(0.1524 mm). In an embodiment, there may be a radius on the back side oflip 65 where lip 65 and upper portion 66 meet. The radius may be sharpto 0.010R. In an embodiment, the radius of mouth 67 that engages a lensmay range between 0.012R-0.020R, preferably about 0.014R. The length oftop jaw 63 and the bottom jaw 64 from the back of mouth 67 may bebetween about 0.045 in. (1.143 mm) and about 0.070 in. (1.778 mm). In anembodiment the length of top jaw 63 is preferably about 0.054 in.(1.3716 mm). The top jaw length may have a relationship (ratio) to thebottom jaw which is about 1.3 to 1 (Top to Bottom). In an embodiment,the relationship may be 1 to 1 or 1 to 1.3 (Top to Bottom).

The features of pushrod 61 as shown in FIGS. 19E-19H may have variousdimensions. The length of the cutout portions 68 may be between about0.150 in. (3.81 mm) to about 0.300 in. (7.62 mm), preferably betweenabout 0.190 in. (4.826 mm) to about 0.250 in. (6.35 mm), more preferablyabout 0.190 in. (4.826 mm). The diameter or width of cutout portion 68as shown may be between about 0.020 in. (0.508 mm) to about 0.030 in.(0.762 mm), preferably about 0.025 in. (0.635 mm) In an embodiment, theradius of mouth 67 that engages a lens may range between 0.010R-0.018R,preferably about 0.013R. The width of the top jaw may be between about0.020 in. (0.508 mm) and about 0.030 in. (0.762 mm) and the width of thebottom jaw may be between about 0.060 in. (1.524 mm) and about 0.040 in.(1.016 mm). The top jaw may be offset from a centerline along thelongitudinal axis of the pushrod. The top jaw length may have arelationship (ratio) to the bottom jaw which is about 1 to 2 (Top toBottom). In an embodiment, the relationship may be 1 to 1 or 1 to 1.3(Top to Bottom). The width of the top jaw may have a relationship to thewidth of the bottom jaw which is about 1 to 2 (Top to Bottom). In anembodiment, where the top portion of the top jaw meets the side wall ofthe notch, the radius of curvature or blending may be about 0.010R.Also, in another embodiment the length of the notch may be about 60% ofthe total length of the pushrod.

Pushrod Flex Tip

As discussed above, FIG. 5 shows an exploded view of pushrod assembly 60which comprises pushrod 61, plunger 24, and nut lock 102.

According to an embodiment of the present invention, pushrod 61comprises distal tip 62 at the distal end of pushrod 61 that has a topjaw 63 and a bottom jaw 64, which is shown in FIG. 19A. Top jaw 63 ofdistal tip 62 is capable of flexing toward bottom jaw 64 shown by arrow“B” to allow the distal tip 62 (or distal end) of pushrod 61 to passthrough the tapered lumen of delivery tube 26. Top jaw 63 may comprise alip 65 that protrudes from an upper portion 66 of top jaw 63 and iscapable of making contact with the lumen of delivery tube 26. FIG. 19Billustrates lip 65 coming in contact with the lumen 70 of delivery tube26 and top jaw 63 flexing toward bottom jaw 64. Lip 65 may makecontinuous or substantially continuous contact with the lumen ofdelivery tube 26 while pushrod 61 is moved longitudinal through deliverytube 26 to eject the IOL out the distal end of the delivery tube. FIG.19C illustrates that once lip 65 of top jaw 63 exits delivery tube 26 atthe distal end, top jaw 63 will flex substantially back into itsoriginal position. Lip 65 can be any configuration or shape that willallow for the flexing of top jaw 63 toward bottom jaw 64. Preferably topjaw 63 is slightly longer or longer than bottom jaw 64 to prevent theIOL from being captured between the two jaws and held after the IOLexits from the delivery tube. According to an embodiment, bottom jaw 64may remain substantially stationary with respect to the rest of pushrod61. In an embodiment, the flexible top jaw 63 allows for further foldingof the trailing haptic of the IOL over the optic during implantation ofthe IOL. The distal tip keeps the trailing haptic in a stable position.

In an embodiment, lip 65 may be located on the bottom jaw 64 dependingupon the geometry of the IOL and/or haptic. For example, if instead ofthe trailing haptic being in a “C” configuration if you look at the IOLin an insertion device from the top, the trailing haptic is in reversed“C” configuration, the lip 65 may function better or properly if it islocated on the bottom jaw 64.

In an embodiment, the bottom jaw 64 may also flex or be capable offlexing toward top jaw 63 to allow the distal tip (or distal end) ofpushrod 61 to pass through the tapered lumen of delivery tube 26. It isalso envisioned that both the top jaw 63 and bottom jaw 64 flex towardseach other as the pushrod 61 is passed through the tapered lumen ofdelivery tube 26.

Tip Protector

An advantage of puller cap 70 is it acts as a tip protector to preventdamage or deformation. As illustrated in FIG. 21, a certain amount ofclearance or space is provided around the distal end of delivery tube 26when puller cap 70 is placed onto system 20. The clearance or space 130is maintained by contact between the internal structures of puller cap70 at the proximal end and system 20. In an embodiment, clearance orspace 130 between delivery tube 26 and the distal end of puller cap 70is maintained by contact between wall 98 through window 97 shown in FIG.15 and wings 27 and portion 96 of lock 95A, B shown in FIG. 7. It isalso envisioned that other similar structures may be used to maintainclearance 130 to protect the tip of delivery tube 26.

Protective Cap

FIGS. 22A-G, 23A-B, 24, 25, and 26 illustrate a protective cap 200 ofthe present invention. Protective cap 200 has similar advantages ofpuller cap 70 of protecting the tip from damage or deformation.Protective cap 200 may be used instead of puller cap 70 when thetrailing haptic is swept or folded by means of the pushrod or thetrailing haptic does not require sweeping or folding. Protective cap 200comprises finger grips 280, window 289, and port 287. Protective cap 200may also comprise one or more of the following: clips (or snaps) 220,relief slots 225, and/or guides 235. Protective cap 200 may alsocomprise a fill indicator 255 and/or a material relief 265.

Protective cap 200 may be made of any material known in the art,preferably polypropylene, polycarbonate, polyethylene, or polyethyleneterephthalate; more preferably polypropylene and polycarbonate; mostpreferably polypropylene. Protective cap 200 may also be of any color,preferably translucent or clear to enable a user to visualize thefeatures inside protective cap 200 and anything housed within protectivecap 200. Protective cap 200 may be the shape as illustrated in theembodiment in FIGS. 22A-G, but the invention also envisions thatprotective cap 200 may be of any shape or size to accommodate the needsof the insertion system the protective cap is used with or the needs ofthe user the puller cap is designed for. For example, the protective capmay be of an arrow shape as illustrated in the embodiment in FIG. 22B,may be more of a round shape, triangular shape, square shape, or shapedto meet the needs for shipping or handling.

The finger grips 280 may be of any design or configuration known in theart. According to an embodiment of the present invention, finger grips280 may comprise a texture design or feature to ease gripping oractuation of the clip 220 and removal of protective cap 200 from aninsertion system, such as system 20 as illustrated in FIGS. 1-5 and1A-4A. The protrusion 282 of finger grips 280 may also be of any shape,including but not limited to square, rounded, triangle, and any othershape known in the art that may assist in grasping protective cap 200.Finger grips 280 may have inner walls that are sized and shaped tocouple with at least a portion of the wings 27 that run along thelongitudinal axis of cartridge 28. The inner walls are configured anddimensioned to avoid damaging the distal end of the tip of the deliverytube 26 when protective cap 200 is placed on the insertion device. In anembodiment, finger grips 280 may have a radius of curvature that issimilar to or mirrors the curvature of a user's finger to assist withgripping and removal of the protective cap 200.

In an embodiment, protective cap 200 comprises tapered portion 245(shown in FIGS. 22B, 22G, 25, and 26). Tapered portion 245 may beconfigured and dimensioned to mirror or substantially mirror the shapeand size of the cartridge and/or insertion device. In an embodiment,tapered portion 245 comprises a bevel 247 which mirrors bevel 23 (shownin FIGS. 2, 2A, and 5). The internal and external walls of taperedportion 245 may also remain uniform or substantially uniform withrespect to each other from the beginning of the tapered portion to at ornear the distal end of cartridge such that the walls run parallel toeach other. It is also envisioned that the internal walls of the taperedportion mirror the external features of the cartridge or distal end ofthe insertion device and the external walls of the tapered portionsremain substantial linear, for example without a bevel.

As shown in FIG. 24, the distal end 285 of protective cap 200 maycomprise internal bevel 270. Internal bevel 270 is configured anddimensioned to match or substantially match or mate with the bevel ofthe tip (at the distal end) of delivery tube 26 of cartridge 28. Whenprotective cap 200 is placed on system 20, internal bevel 270 is coupledwith the bevel of the tip of delivery tube 26 of cartridge 28 and port287, and with its funnel feature it creates a larger opening Asdiscussed above, the small nature of ports can make it very difficultfor doctors, nurses, and/or staff to locate openings for insertingfluids. Port 287 with internal bevel 270 enables a user to more easilydirect a cannula tip 101 into a delivery tube 26 or port 87 asillustrated in FIG. 8.

As illustrated in FIGS. 22A, C, E, and G, the distal end of protectivecap 200 may also comprise a material relief 265. Material relief 265helps prevent distortion of the tip at the distal end of protective cap200 during the molding process. It is also envisioned, that the distalend of the protective cap 200 does not comprise a material relief.

As illustrated in FIG. 23A, protective cap 200 may also have inner wallscomprising one or more internal guides 235 that run along at least aportion of the longitudinal axis and are configured and dimensioned tomate or couple with features on the outer portions of the insertiondevice. Internal guides 235 help keep the protective cap substantiallyaligned in a horizontal and vertical direction when the cap is placed onor removed. This helps to protect the distal end or tip of cartridge 28or insertion system 20. The internal guides 235 may be of any width orof any length suitable to couple with external features of the insertionsystem and/or cartridge. According to an embodiment, there may be twointernal guides on the internal wall of the protective cap along thelongitudinal axis, and the distance between each of the guides may beany distance as long as it matches the external features on theinsertion system. In an embodiment, the distance between the guides maybe about 0.374 in. (9.4996 mm) apart. The width of a guide may bebetween about 0.023 in. (0.5842 mm) and about 0.028 in. (0.7112 mm),preferably about 0.025 in (0.635 mm). In an embodiment, the length of aguide may be between about 0.318 in. (8.0772 mm) and about 0.386 in.(9.8044 mm). The length of a guide may also be between about 0.318 in.(8.0772 mm) and about 0.328 in. (8.3312 mm), preferably about 0.323 in.(8.2042 mm) The length of the guide may also be between about 0.376 in.(0.5504 mm) and 0.386 in. (9.8044 mm), preferably about 0.381 in.(9.6774 mm) In another embodiment, one or more guides may begin at ornear the distal end of relief slot 225 (see FIG. 23A) and extend for adistance toward the distal end of the protective cap.

As discussed above, the small nature of ports can make it very difficultfor doctors, nurses, and/or staff to locate openings for insertingfluids. The protective cap 200 of the present invention solves thisproblem by providing a larger port 287 with a funnel feature that leadsinto the smaller port of the insertion device. This enables a user tomore easily direct a cannula tip 101 into a delivery tube 26 or port 87as illustrated in FIG. 8. The protective cap may also include one ormore additional ports.

Protective cap 200 may also have one or more windows 289 to provide theusers with a visual indicator of the amount of fluid inserted into theinsertion system, as well as provide viewing of the distal end of acannula tip. The one or more windows may be located on the top, bottomor sides of the protective cap, preferably on the top or the bottom. Theone or more windows may also comprise a measuring devise such as a rulerto allow a user to measure the amount of fluid inserted into theinserter. The one or more windows may also comprise a material such thatwhen a fluid is inserted into the inserter and viewed through the windowlight that is emitted through the window to the fluid is polarizedproviding a visual indicator of the fluid within the inserter. Thewindow 289 may also comprise a fill indicator 255 to provide a maximumfill line.

In order to secure protective cap 200 to an insertion system, such asthe system 20 shown in FIGS. 1 and 1A, clip 220 may be used. Clip 220 isconfigured and dimensioned to mate with a distal portion of wings 27 ofcartridge 28 (cartridge 28 is shown in FIG. 5). In an embodimentillustrated in FIG. 25, relief slots 225 of protective cap 200 couplewith the vertical elements 29 (shown in FIG. 5) of wings 27 of cartridge28. Relief slots 225 may be of any shape or size to couple with theshape or size of the vertical elements 29. Clip 220 may also extendbeyond the proximal end of finger grips 280 as illustrated in FIG. 22B.

In an embodiment, when the protective cap 200 is placed on the distalend of the system 20, clips 220 act as a cantilever snap by riding alongthe vertical elements 29 of the wings 27 of cartridge 28 until the clips220 are over center and then snapping down over the end of the wings 27.In an embodiment, the clip 220 is not located on the grip 280 to allowfor easier removal of the protective cap. It is also envisioned thatclip 220 may be located or coupled with the grip 280 depending upon thedesign and/or function of the clip 220 and whether the grip 280 is anextension of the clip 220.

FIGS. 27A-F and 28A-F illustrate additional embodiments of a protectivecap with similar features as shown in FIGS. 22A-22G, 23A-23B, and 24.FIGS. 29A-F and FIGS. 30A-F illustrate additional embodiments of apuller cap with similar features as shown in FIGS. 6-13.

Plunger Marker

As illustrated in FIGS. 31A and 31B, plunger 24 may comprise a marker orindicator 310. As discussed above, the plunger 24 and/or pushrod 61(pushrod assembly 60) translates axially through an elongate passagedefined within the inserter handpiece 22 and is configured to urge theIOL from a holding station 30 through the distal delivery tube 26. In anembodiment, system 20 may operate in a push and/or twist fashion. With apush and twist mechanism, the plunger 24 may first be advanced axiallyalong the longitudinal axis to a predetermined point and then theplunger 24 may be rotated for further advancement. Such a furtheradvancement via rotation may provide additional control in the deliveryof the IOL. In such a scenario, it would be helpful to provide anindication of when the axial translation of the plunger 24 or pushrodassembly 60 has reached the predetermined point. In such an embodiment,a marker 310 is placed on plunger 24 such that when the plunger 24 isadvanced or displaced along the longitudinal axis of the system 20 auser will be able to visualize that the plunger has reached thepredetermined point when marker 310 lines up with the proximal end 320of handpiece 22 (see FIG. 31B) or disappears within handpiece 22 (seeFIG. 31C). Marker 310 may be placed on any location on plunger 24 andmay be of any shape, size or color. The predetermined point may be theproximal end 320 as described in the above embodiment, but it is alsoenvisioned to be any location along the handpiece 22. This may bepossible if handpiece 22 is made of a translucent or transparentmaterial such that marker 310 is visible through handpiece 22.

Pushrod Supports

According to an embodiment, the present invention provides one or moreguide rails to provide support for the pushrod on the distal end of theinserter body. FIG. 32 shows a cross-sectional view of insertion system20 with pushrod 61 and handpiece 22. According to an embodiment, pushrod61 may comprise one or more guide rails 395, preferably a guide rail onopposite sides of pushrod 61. To mate with guide rails 395, one or morechannels 396 on the upper and/or lower portions of lens holding station30 may be included. The top and/or bottom channels 396 may be of anyshape to mate with the shape of the one or more guide rails. Preferablythe guide rails and channels are substantially rectangular in shape.Preferably, the lower channel is wider than the upper channel, althoughthe width of the channels can be of any size and the channels can be ofany shape. The guide rails on the pushrod mate to the channels and mayhave substantially the same shape. The guide rails may be on any portionof the pushrod and may make up any percentage of the pushrod. Thechannels may be located on other locations of the handpiece 22,including but not limited to base 52 and/or delivery tube 26.

According to an embodiment, it is also envisioned that one or more guiderails may be located on the handpiece 22 and corresponding channels maybe located on the pushrod 61. In an embodiment, the channels may belocated a long a portion of the pushrod 61 and may be found on anylocation around the circumference of the pushrod. The one or more guiderails may be located anywhere within the handpiece such that the guiderails are configured and dimensioned to mate with the one or morechannels located on the pushrod 61.

Nut Lock

In insertion systems, advancing an IOL through a delivery tube involvesa significant amount of force. To allow for advancement of an IOL from alens storage area/holding station to a loading area the same mechanismdescribed above can be used. For ease of use a pushing mechanism may beused to advance a lens from a storage/holding station into a deliverytube for insertion and then the same mechanism can be used to insert theIOL using a twisting mechanism. To allow for the push and twist andaccommodate the high amount of force, the present invention incorporatesa nut lock to prevent the pushrod from moving proximally as the pushrodis rotated to move the IOL distally.

FIG. 33 illustrates an embodiment of the present invention. Nut lock 102may have an internal thread of a load bearing quality. Nut lock 102 maybe cylindrical in shape and have a centrally located groove 401 thatallows interlock and/or detent with external/internal features ofhandpiece 22. On the distal portion of nut lock 102 there may be aseries of radial keyways 402 that are capable of mating with keys (notshown) protruding inward from handpiece 22 that prevent it from counterrotating. Nut lock 102 may be made of any material known in the art,including but not limited to plastic, metal, and ceramic. Nut lock 102may be coupled with the plunger 24 via load bearing threads and issandwiched between plunger 24 and pushrod 61, which may be snappedtogether or coupled together in any way known in the art.

According to an embodiment, nut lock 102 may comprise a single leadthread, but may comprise more (multiple). Nut lock 102 may also havevarying thread pitch.

According to an embodiment, when the insertion system is delivered to aphysician's office, pushrod assembly 60 is in a first position. In thisfirst position, the pushrod assembly 60 is in its most proximal positionand groove 401 of nut lock 102 mates with one or more proximal detents407 located at or near the most proximal end of handpiece 22 andprevents accidental movement of pushrod assembly 60. At this point,plunger 24 can be rotated in any direction without causing longitudinalmovement of pushrod 61. When the pushrod assembly is moved into a secondposition between the most proximal detent 407 and a second distal detent406, pushrod assembly 60 is movable in a longitudinal direction betweendetents, but rotation of plunger 24 in any direction does notlongitudinally move pushrod 61. When pushrod assembly 60 is moveddistally in a longitudinal direction to a third position, wherein groove401 of nut lock 102 mates with one or more distal detents 406 (seconddetent position) (see FIG. 33A), pushrod assembly 60 is prevented fromfurther distal or proximal movement by pushing or pulling on end cap 40.Once in the second detent position, the pushrod assembly cannot bepulled from this position back to the first proximal position. At thispoint the only way to advance pushrod 61 longitudinally to insert theIOL is to rotate plunger 24 via end cap 40 in either a clockwise orcounter-clockwise direction (depending upon the configuration of thethreads). This is to prevent reuse of a one time use insertion systemand/or improper activation of the pushrod.

The detents are one way snaps (cantilever snaps) that provide thestrength to prevent the pushrod assembly 60 from being pulled back fromthe second detent 406 (see FIG. 33A). The proximal detent(s) 407 alsoprovide biasing for the proximal end of the plunger 24 as it is advancedlongitudinally or rotated and provide a little resistance (see FIG.33B). The proximal detents 407 may be the same or similar to the seconddetent 406. The proximal detents 407 may have a different configurationor shape from the second detent 406. The detents may be of any shape orsize suitable for its function.

Safety Detent for Plunger Threads

According to an embodiment, to help prevent advancing the pushrod withrotation of plunger 24 until desired, detents 405 are added to theplunger. Detents 405 are located on the distal end or portion of plunger24. According to an embodiment, the detents are located within the firsttwo to three threads of plunger 24. FIG. 34 illustrates detents 405 atthe distal end or portion of plunger 24. The number of detents can rangebetween 1-6, preferably 4.

All references cited herein are hereby incorporated by reference intheir entirety including any references cited therein.

The above presents a description of the best mode contemplated ofcarrying out the present invention, and of the manner and process ofmaking and using it, in such full, clear, concise, and exact terms as toenable any person skilled in the art to which it pertains to make anduse this invention. This invention is, however, susceptible tomodifications and alternate constructions from that described abovewhich are fully equivalent. Consequently, it is not the intention tolimit this invention to the particular embodiments disclosed. On thecontrary, the intention is to cover modifications and alternateconstructions coming within the spirit and scope of the invention asgenerally expressed by the following claims, which particularly pointout and distinctly claim the subject matter of the invention.

1. A pushrod tip, comprising: a top jaw; and a bottom jaw; wherein thetop jaw and bottom jaw are coupled together to form an openingconfigured and dimensioned to couple with an intraocular lens; whereinthe top jaw is capable of flexing towards the bottom jaw when thepushrod tip is passed through a lumen.
 2. The pushrod tip of claim 1,wherein the top jaw further comprises a lip coupled to the bottom jaw,wherein the lip is configured and dimensioned to flex the top jaw whenthe pushrod tip is passed through the lumen.
 3. The pushrod tip of claim2, wherein the lip is located on a periphery of the top jaw such thatthe tip comes in contact with the lumen and not the top jaw.
 4. Thepushrod tip of claim 1, wherein the bottom jaw further comprises a lipcoupled to the bottom jaw, wherein the lip is configured and dimensionedto flex the bottom jaw when the pushrod tip is passed through the lumen.5. The pushrod tip of claim 1, wherein the lumen is tapered.
 6. Thepushrod tip of claim 1, wherein the bottom jaw remains substantiallyrigid when compared to the top jaw.
 7. The pushrod tip of claim 1,wherein the top jaw is longer than the bottom jaw.
 8. The pushrod tip ofthe claim 1, wherein the top jaw and the bottom jaw release theintraocular lens once the intraocular lens exits the lumen.
 9. Aninsertion system, comprising: a handpiece having a longitudinal axis, adistal end, and a proximal end; and a pushrod assembly having a distalend and a proximal end, wherein the pushrod assembly comprises a pushrodand a plunger; wherein the pushrod assembly couples with the handpiecebody along the longitudinal axis; wherein the pushrod is coupled withthe plunger and the pushrod is located on the distal end of the pushrodassembly and the plunger is located on the proximal end of the pushrodassembly; wherein the pushrod or the handpiece comprises one or moreguide rails, wherein the one or more guide rails are configured anddimensioned to couple with one or more channels of the pushrod or thehandpiece.
 10. The insertion system of claim 9, wherein the one or moreguide rails have a substantially rectangular shape.
 11. The insertionsystem of claim 9, wherein the one or more channels have a substantiallyrectangular shape.
 12. The insertion system of claim 9, wherein thereare two guide rails and two channels and wherein one channel and oneguide rail are larger than the other rail and channel.
 13. The insertionsystem of claim 9, wherein the handpiece comprises the one or morechannels and further comprises a holding station and wherein at least aportion of the one or more channels are located within the holdingstation.
 14. The insertion system of claim 9, wherein the handpiececomprises the one or more guide rails and the pushrod comprises the oneor more channels, and wherein the handpiece further comprises a holdingstation wherein at least a portion of the one or more guide rails arelocated within the holding station.
 15. An insertion system, comprising:a handpiece comprising one or more detents, and one or more keys; and apushrod assembly comprising a pushrod, a plunger, and a nut lock,wherein the nut lock comprises a series of radial keyways and a groove,wherein the groove of the nut lock is configured and dimensioned to matewith the one or more detents of the handpiece, and wherein the series ofradial keyways are configured and dimensioned to mate with the one ormore keys of the handpiece.
 16. The insertion system of claim 15,wherein the nut lock is coupled between the pushrod and the plunger. 17.The insertion system of claim 15, wherein the plunger comprises one ormore detents located on a distal portion.
 18. A method of preparing aninsertion system, comprising: providing an insertion system in a firstposition, wherein the insertion system comprises a handpiece having alongitudinal axis, a proximal portion, and a distal portion, andcomprising a first detent, a second detent, and one or more keys; and apushrod assembly comprising a pushrod, a plunger, and a nut lock,wherein the nut lock comprises a series of radial keyways and a groove,wherein the groove of the nut lock is configured and dimensioned to matewith the first detent and the second detent of the handpiece, andwherein the series of radial keyways are configured and dimensioned tomate with the one or more keys of the handpiece; and wherein the firstposition comprises the groove being mated with the first detent locatedat the proximal portion of the handpiece, wherein rotation of theplunger does not advance the pushrod along the longitudinal axis;pushing the pushrod assembly to a second position along the longitudinalaxis in a distal direction, wherein the second position is between thefirst detent and the second detent, wherein rotation of the plunger doesnot advance the pushrod along the longitudinal axis; pushing the pushrodassembly to a third position along the longitudinal axis in the distaldirection, wherein in the third position the groove is mated with thesecond detent of the handpiece; and rotating the plunger to advance thepushrod along the longitudinal axis in the distal direction to advancethe intraocular lens through the handpiece, wherein pushing the plungerdoes not advance the pushrod along the longitudinal axis.
 19. A pushrod,comprising: a top jaw having a first side and a second side along alongitudinal axis of the pushrod; and a bottom jaw having a first sideand a second side along the longitudinal axis of the pushrod; whereinthe top jaw and the bottom jaw are coupled together; and wherein the topjaw comprises a notch on the first side along the longitudinal axis ofthe pushrod that is configured and dimensioned to couple with anintraocular lens when the pushrod tip is passed through a lumen.
 20. Thepushrod of claim 19, wherein the notch is L-shaped.
 21. The pushrod ofclaim 19, wherein the notch extends beyond the top jaw into a body ofthe pushrod.
 22. The pushrod of claim 19, wherein the bottom jawcomprises a notch along a longitudinal axis of the pushrod that isconfigured and dimensioned to couple with an intraocular lens when thepushrod tip is passed through a lumen.
 23. The pushrod of claim 19,wherein the top jaw comprises a second notch on the second side alongthe longitudinal axis of the pushrod.
 24. The pushrod of claim 19,wherein the bottom jaw is longer than the top jaw.
 25. The pushrod ofclaim 19, wherein the top jaw is configured and dimensioned to engage atrailing haptic before the bottom jaw engages a lens body.
 26. Thepushrod of claim 19, wherein the top jaw is configured and dimensionedto couple with and ride along at least a portion of a channel of astaging area of an insertion device.
 27. The pushrod of claim 19,wherein the top jaw has a height that is greater than the height of ahaptic to ensure the top jaw consistently engages the haptic.
 28. Thepushrod of claim 19, wherein the notch extends into a portion of thebottom jaw.
 29. The pushrod of claim 28, wherein the top jaw comprises asecond notch on the second side along the longitudinal axis of thepushrod.
 30. The pushrod of claim 29, wherein the second notch extendsinto a portion of the bottom jaw.
 31. An insertion system, comprising: ahandpiece having a longitudinal axis, a distal end, and a proximal end,a pushrod assembly having a distal end and a proximal end, wherein thepushrod assembly comprises a pushrod and a plunger; wherein the pushrodassembly couples with the handpiece along the longitudinal axis; whereinthe pushrod is coupled with the plunger and the pushrod is located onthe distal end of the push rod assembly and the plunger is located onthe proximal end of the pushrod assembly; wherein the plunger isconfigured and dimensioned to advance the pushrod toward the distal endof the handpiece along the longitudinal axis by rotation of the plungerand translational movement of the plunger; wherein the plunger comprisesthreads and one or more safety detents, wherein the one or more safetydetents are located on a distal end of the plunger on one or more of thethreads; and wherein the one or more safety detents are configured anddimensioned to prevent advancement of pushrod with rotation of theplunger until such rotation is desired.
 32. The insertion system ofclaim 31, wherein the one or more safety detents are located within thefirst two or three threads from the distal end of the plunger.
 33. Theinsertion system of claim 32, wherein the threads comprise one to sixsafety detents.
 34. The insertion system of claim 32, wherein thethreads comprise four safety detents.